Colposcopic biopsy punch with removable multiple sample basket

ABSTRACT

A colposcopic surgical punch instrument includes a hollow tube and a push rod extending through the hollow tube. A handle is coupled to the proximal end of the tube and an actuation lever is pivotally coupled to the handle and the proximal end of the push rod for effecting axial movement of the push rod relative to the tube. A stationary jaw in the form of a die having an open top and bottom is coupled to the distal end of the tube and a movable jaw in the form of a punch is pivotally coupled to the stationary jaw by a tongue and groove arrangement. In one embodiment, the stationary jaw is provided with a pair of ramped projections on its sides and a tab projection on its distal end. A removable plastic sleeve fits over the stationary jaw. The plastic sleeve has an open proximal end and an open top. A pair of holes in the sides of the sleeve engage the ramped projections on the sides of the stationary jaw and a hole in the distal end of the sleeve engages the distal tab on the stationary jaw. The top opening of the sleeve is dimensioned to allow free movement of the movable jaw into and out of the stationary jaw. When attached to the stationary jaw, the sleeve functions as a multiple sample basket beneath the open bottom of the stationary jaw. In another embodiment, the jaw has surface recesses and the sleeve has interior projections.

This application is related to co-owned U.S. application Ser. No.07/978,249 filed Nov. 18, 1992 now U.S. Pat. No. 5,395,375, applicationSer. No. 08/101,190 filed Aug. 3, 1993 now U.S. Pat. No. 5,309,104, andapplication Ser. No. 08/180,434 filed Jan. 12, 1994 now abandoned, allof which are incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention broadly relates to surgical instruments. Moreparticularly, the invention relates to colposcopic biopsy instrumentswhich have a punch end effector with means for collecting multiplebiopsy samples.

2. State of the Art

The colposcopic biopsy procedure has become a widely practiced surgicalprocedure. The colposcope is an optical instrument, similar to anendoscope, which is used in conjunction with an endocervical speculum toexamine the cervix. The procedure essentially involves inserting thespeculum through the vagina and placing the distal end of the colposcopeinto the speculum. The speculum is manipulated until the cervix is at aright angle to the light of the colposcope. Upon examination, ifabnormality of the cervical tissue is observed, one or several biopsysamples are obtained from one or several cervical locations with the useof a colposcopic biopsy forceps.

Colposcopic biopsy forceps generally include an actuating handle coupledby rods to an end effector assembly. The end effector assembly typicallyincludes a pair of jaws one of which is rotatably coupled to the other,thereby allowing articulation of one of the end effectors relative tothe other. The jaws are intended to achieve a cutting action through apunch and die configuration which severs the tissue from the joint bypunching the tissue with a sharp edged jaw through a die. The dietypically takes the form of a stationary jaw, while the punch takes theform of a movable jaw which rotates relative to the stationary jaw froman open position to a closed position when cutting. Some of theseinstruments take small, relatively superficial samples unless thepractitioner stabilizes the cervix because they tend to slip away fromthe tissue as the jaws are closed. These instruments often crush ratherthan cut through the epithelium, often producing an unsatisfactoryspecimen. Other instruments have serrations on the die which aid instabilizing the biopsy area. Still other instruments provide tooth-likeprojections on the punch which effectively stabilize the cervix, buttend to make a very deep cut resulting in excessive bleeding.

When collecting biopsy samples of the cervix, it is very important torecord the location from which each sample was taken. The normalprocedure is to take one sample, remove the forceps, and deposit thesample in an individual container. The forceps are then reintroducedthrough the speculum and another sample is taken. Typically, each sampleis captured in and by the punch end effector so that it does not fallthrough the die. This arrangement makes it impossible to take multiplesamples since the second sample would either fall through the die endeffector or cause the first sample to become dislodged from the punchend effector.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide a surgical punchinstrument which is capable of collecting multiple cervical tissuesamples.

It is also an object of the invention to provide a surgical endoscopicpunch instrument which has enhanced strength.

It is another object of the invention to provide a surgical punchinstrument which is useful in both single and multiple cervical biopsycollection procedures.

It is a further object of the invention to provide a surgical punchinstrument which is easily and quickly adaptable to perform both singleand multiple cervical biopsy collection procedures.

In accord with these objects which will be discussed in detail below,the surgical punch instrument of the present invention includes a hollowtube having a proximal and a distal end, a push rod having a proximaland a distal end extending through the hollow tube, a stationary jawcoupled to the distal end of the hollow tube, a movable jaw coupled tothe distal end of the push rod and to the stationary jaw, and aremovable sleeve which is removably attached to the stationary jaw. Thestationary jaw is in the form of a die having an open top and an openbottom and at least one surface engagement means for engaging theremovable sleeve. The movable jaw is in the form of a punch and ispivotally coupled to the stationary jaw for movement into and out of theopen top of the stationary jaw. A handle is coupled to the proximal endof the tube and an actuation lever is pivotally coupled to the handleand the proximal end of the push rod for effecting axial movement of thepush rod relative to the tube, thereby effecting movement of the movablejaw punch into and out of the stationary jaw die.

According to a preferred aspect of the present invention, the removablesleeve is a plastic sleeve which fits over the stationary jaw. Theplastic sleeve is provided with an open proximal end, an open top, aclosed bottom basket, and at least one means for engaging the stationaryjaw. The top opening of the sleeve is dimensioned to allow free movementof the movable jaw into and out of the stationary jaw. When attached tothe stationary jaw, the sleeve functions as a multiple sample basketbeneath the open bottom of the stationary jaw.

According to one embodiment of the invention, attachment of the sleeveto the stationary jaw is facilitated by providing the sides of thestationary jaw with a pair of ramped projections, the distal end of thestationary jaw with a tab projection, and by providing the sides of thesleeve with a pair of holes which engage the ramped projections on thesides of the stationary jaw and the distal end of the sleeve with a holewhich engages the distal tab on the stationary jaw. The engagement ofthe sleeve with the ramped projections on the jaw prevent it frominadvertently slipping off the jaw in the distal direction. Theengagement of the distal end of the sleeve with the distal tab preventsthe sleeve from being deflected away from the bottom of the jaw. Theplastic sleeve is preferably somewhat elastic so than it can be attachedto and removed from the jaw without breaking, but not so elastic that itcan be inadvertently detached from the jaw during a biopsy procedure. Inanother embodiment of the invention, the sleeve has inwardly extendingprojections and the jaw has external recesses which receive and engagethe inwardly extending projections on the sleeve.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is partially transparent side elevation view of a surgical punchinstrument according to the invention;

FIG. 1a is an enlarged cross-sectional view of an indicated portion ofthe instrument of FIG. 1;

FIG. 2 is a partially transparent enlarged broken side elevation view ofthe distal end of a first embodiment of the instrument with the jaws inthe open position;

FIG. 3 is a view similar to FIG. 2 with the jaws in the closed position;

FIG. 4 is a top plan view of the first embodiment of the stationary jawaccording to the invention;

FIG. 5 is an enlarged perspective view of a first embodiment of theplastic sleeve according to the invention;

FIG. 6 is a view similar to FIG. 2 with a plastic sleeve attached to thestationary jaw;

FIG. 7 is a view similar to FIG. 4 with a plastic sleeve attached to thestationary jaw;

FIG. 8 is a view similar to FIG. 3, but of a second embodiment of theinvention;

FIG. 9 is a view similar to FIG. 4, but of the second embodiment of theinvention;

FIG. 10 is a view similar to FIG. 5 of a second embodiment of theplastic sleeve according to the invention;

FIG. 11 is a view similar to FIG. 6, but of the second embodiment of theinvention, and with the movable jaw in the closed position; and

FIG. 12 is a view similar to FIG. 7, but of a second embodiment of theinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1 through 4, the surgical punch instrument 10according to the invention resembles an arthroscopic punch and includesa hollow tube 12 and a push rod 14 which extends through the tube 12.The tube 12 may optionally be provided with an insulating shrink wrapcovering 13 as described in the previously incorporated applications.The proximal end of the tube 12 is coupled to a handle 16 and theproximal end of the push rod 14 is coupled to a lever 18 which ispivotally coupled to the handle 16. Movement of the lever 18 relative tothe handle 16 therefore imparts a reciprocal axial movement to the rod14 relative to the tube 12 as shown by the arrows 20 in FIG. 1.

As described in detail in the co-owned related applications cited above,a stationary jaw 22 is coupled to the distal end of the tube 12, and amovable jaw 24 is coupled to the distal end of the push rod 14. Themovable jaw 24 has a pair of arcuate grooves 26, 28 and the stationaryjaw 22 has a pair of arcuate flanges 30, 32 which engage the grooves 26,28 on the movable jaw 24. The stationary jaw 22 has an upper opening 34and a lower opening 36. The movable jaw 24 is therefore movable into andout of the upper opening 34 of the stationary jaw 22 by action of thelever 18. The movable jaw 24 has sharp cutting teeth 25 which coact withthe inner surface 35 of the upper opening 34 of the stationary jaw 22when the movable jaw is moved from the open position shown in FIG. 2 tothe closed position shown in FIG. 3. The jaws thus act like a punch anddie to cut tissue and pieces of cut tissue are freely removable from thejaws through the bottom opening 36 of the stationary jaw 22.

According to a first embodiment of the present invention, the outersurface of the stationary jaw 22 is provided with a pair of outwardlyextending ramped projections 40, 42 and a outwardly extending distal tabprojection 44. The ramped projections 40, 42 are preferably located onthe sides of the jaw 22 proximal of the upper and lower openings 34, 36and ramp outward in the proximal direction. The distal tab projection 44preferably extends from the distal end of the jaw 22 in a directionsubstantially parallel to the longitudinal axis of the jaw, although itmay also be angled if desired.

Turning now to FIGS. 5-7, a first embodiment of a removable plasticsleeve 50 is seen to be designed to fit over the stationary jaw 22. Thesleeve 50 has a proximal opening 52, an upper opening 54, a pair of sideopenings 56, 58, and a distal end. opening 60. The proximal opening 52of the plastic sleeve 50 is dimensioned to allow the sleeve 50 to slideover the jaws 22, 24 when they are in the closed position. The upperopening 54 is dimensioned to allow the movable jaw 24 to move freelyinto and out of the stationary jaw 22 when the sleeve 50 is attached tothe jaw 22. The side openings 56, 58 of the sleeve 50 are located anddimensioned to engage the ramped projections 40, 42 and the distal endopening 60 is located and dimensioned to engage the distal tabprojection 44. When the sleeve 50 is attached to the jaw 22 as shown inFIGS. 6 and 7, the bottom opening 36 of the jaw 22 is covered by thesleeve 50 so that cut tissue, e.g. a biopsy sample, cannot fall out ofthe bottom opening 36 in the jaw 22. The sleeve 50 thereby acts as acollection basket so that multiple samples may be collected. The sideopenings 56, 58 engage the ramped projections 40, 42 so that the sleeve50 cannot inadvertently slide off the jaw 22 and the distal end opening60 engages the distal tab projection 44 so that the sleeve 50 cannot beinadvertently deflected away from the bottom of the jaw 22. It will beappreciated that the dimensions of the sleeve 50 should be such that thesleeve fits snugly over the jaw 22. Moreover, those skilled in the artwill appreciate that the sleeve 50 should have a sufficient amount ofelasticity so that it can slide over the ramped projections 40, 42 andstill be removable from the jaw 22 without breaking; but not so muchelasticity that the sleeve can inadvertently slide off the jaw during abiopsy procedure.

If desired, the sleeve 50 may be provided with small holes (not shown)on its bottom surface 57 and one or more of its side surfaces 59. Suchholes would be dimensioned to guarantee that biopsy samples would notinadvertently fall out of the sleeve 50, but would be large enough topermit extraction of biopsy samples while the sleeve 50 is fixed on thejaw 22 via tweezers or a hook.

FIGS. 8 through 12 show a second embodiment of the invention. Thestationary jaw 122 according to the second embodiment is similar to thejaw 22 of the first embodiment with similar reference numerals denotingsimilar features. The second embodiment of the jaw 122 has a pair ofside recesses or indents 140, 142 rather than ramped projections asshown in the first embodiment. Jaw 122 is also provided with a distalrecess or indent 144 rather than a distal tab extension as shown in thefirst embodiment. The movable jaw 124 used with the stationary jaw 122is virtually identical to the movable jaw 24 described above.

In the second embodiment of the invention, the removable plastic sleeve150 is similar to the sleeve 50 of the first embodiment with similarreference numerals denoting similar features. The sleeve 150 has a pairof ramped inner projections 156, 158 on the side surface 159 rather thanthe side openings as shown in the first embodiment. The rampedprojections 156, 158 are located near the proximal opening 152 of thesleeve 150 and ramp inward in the proximal direction. The distal end ofthe sleeve 150 has an inward extending tongue 160 rather than a distalend opening as shown in the first embodiment.

From the foregoing, those skilled in the art will appreciate that thesecond embodiment of the invention operates in substantially the samemanner as the first embodiment except that projections and recesses havebeen exchanged with each other. It will further be appreciated that theengaging means 40, 42, 44, 140, 142, 144 on the jaw 22, 122 may be anycombination of projection and/or recess. Similarly, the engaging means56, 58, 60, 156, 158, 160 on the sleeve 50, 150 may also be anycombination of projection and/or recess. It is only necessary that theprojections on one of the jaw and sleeve engage the recesses on theother of the jaw and sleeve.

The operation of the punch instrument in a colposcopic procedure is asfollows. The colposcopic examination is commenced in the normal way withthe insertion of the speculum and the colposcope. The practitionerobserves the cervix and determines whether one or more biopsy samplesare to be taken. If multiple samples are to be taken from a singlelocation, the sleeve 50, 150 is attached to the instrument as describedabove, and the instrument is inserted through the speculum under theobservation of the colposcope. The practitioner locates the portion ofcervical tissue requiring biopsy, opens the jaws of the instrument andbrings them into engagement with the tissue. As the jaws are closed,through operation of the lever 18, the sharp cutting teeth 25 stabilizethe biopsy area and pull the tissue into the upper opening 34 of thestationary jaw 22. The teeth 25 coact with the inner surface 35 of theopening 34 and a tissue sample is severed from the cervix. The tissuesample is pushed by the movable jaw 24 into the stationary jaw 22 whereit resides in the opening 360. To take a second sample, the procedure isrepeated and the second sample pushes the first sample further into thesample basket formed by the sleeve 50, 150. Additional samples may betaken as required. After the required samples have been taken, theinstrument is removed from the speculum. The samples may be recovered inseveral ways. First, the sleeve 50, 150 can be removed from theinstrument and the samples taken. Second, in the case of a sleeve havingholes, the samples may be grapsed by a tweezers or the like, andforcibly removed through the holes. Third, the punch instrument with thejaw in an open position can be turned upside down and jostled until thesamples fall out. It will be appreciated that the instrument can be usedwith or without the sample basket depending on the needs of thepractitioner.

There has been described and illustrated herein a surgical punchinstrument having a removable biopsy sample basket. While particularembodiments of the invention have been described, it is not intendedthat the invention be limited thereto, as it is intended that theinvention be as broad in scope as the art will allow and that thespecification be read likewise. Thus, while particular engagingprojections on the stationary jaw or the removable sleeve have beendisclosed, it will be appreciated that other projections in otherlocations could be utilized. Also, while particular holes or recesses onthe stationary jaw or the removable sleeve have been shown, it will berecognized that other types of holes or recesses in other locationscould be used with similar results obtained. For example, since it isthe primary purpose of the sleeve to cover the open bottom of the jaw,the sleeve and jaw may be configured so that the sleeve mountsvertically from below the jaw rather than sliding horizontally on to thejaw. It will thus be appreciated that the sleeve can be shaped like abasket or a scoop. In any case, the sleeve should be coupled to the jawat at least two locations for stability. Moreover, while particularconfigurations have been disclosed in reference to tongue and groovecoupling of the jaw members, it will be appreciated that otherconfigurations could be used as well. Furthermore, while the jaw andsleeve have been disclosed as having three engagement means, it will beunderstood that different numbers of engagement means can achieve thesame or similar function as disclosed herein. It will therefore beappreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as so claimed

We claim:
 1. A surgical punch instrument for cutting tissue, and for usewith a removable sleeve, comprising:a) a hollow tube having a proximaland a distal end; b) a push rod having a proximal and a distal end, saidpush rod extending substantially through said hollow tube; c) a handlecoupled to said proximal end of said tube; d) a lever pivotally coupledto said handle and coupled to said proximal end of said push rod forimparting axial movement to said push rod relative to said tube; e) afirst jaw coupled to said distal end of said tube, said first jaw beinga die and having an open top and an open bottom and at least oneexterior engaging means for engaging the removable sleeve; and f) amovable jaw pivotally coupled to said first jaw and coupled to saiddistal end of said push rod, said movable jaw being a punch, whereinwhen said movable jaw pivots relative to said first jaw towards a closedposition, said movable jaw punches the tissue and the tissue dropsthrough said open bottom of said first jaw.
 2. A surgical punchinstrument according to claim 1, further comprising:g) a removablesleeve having a proximal opening, a top opening, and an interiorengaging means for engaging said at least one exterior engaging means.3. A surgical punch instrument according to claim 1, wherein:said atleast one exterior engaging means comprises a pair of surfaceprojections on opposite sides of said first jaw.
 4. A surgical punchinstrument according to claim 3, further comprising:g) a removablesleeve having a proximal opening, a top opening, and pair of sideopenings for engaging said pair of surface projections.
 5. A surgicalpunch instrument according to claim 4, wherein:said pair of surfaceprojections are ramped.
 6. A surgical punch instrument according toclaim 3, wherein:said pair of surface projections are ramped.
 7. Asurgical punch instrument according to claim 1, wherein:said at leastone exterior engaging means comprises a distal tab projection on adistal end of said first jaw and a pair of surface projections onopposite sides of said first jaw.
 8. A surgical punch instrumentaccording to claim 7, further comprising:g) a removable sleeve having aproximal opening, a top opening, and a pair of side openings forengaging said pair of surface projections, and a distal end opening forengaging said distal tab projection.
 9. A surgical punch instrumentaccording to claim 8, wherein:said pair of surface projections areramped.
 10. A surgical punch instrument according to claim 7,wherein:said pair of surface projections are ramped.
 11. A surgicalpunch instrument according to claim 1, wherein:said at least oneexterior engaging means comprises a pair of surface recesses on oppositesides of said first jaw.
 12. A surgical punch instrument according toclaim 11, further comprising:g) a removable sleeve having a proximalopening, a top opening, and pair of interior side projections forengaging said pair of surface recesses.
 13. A surgical punch instrumentaccording to claim 1, wherein:said at least one exterior engaging meanscomprises a distal recess on a distal end of said first jaw and a pairof surface recesses on opposite sides of said first jaw.
 14. A surgicalpunch instrument according to claim 13, further comprising:g) aremovable sleeve having a proximal opening, a top opening, and a pair ofinterior side projections for engaging said pair of surface recesses,and an interior distal end tongue for engaging said distal recess.
 15. Asurgical punch instrument according to claim 1, wherein:said first jawis stationary relative to said tube.
 16. A surgical punch instrumentaccording to claim 1, further comprising:g) a removable sleeve having atop opening, and means for engaging said first jaw.
 17. A surgical punchinstrument for cutting tissue, comprising:a) a hollow tube having aproximal and a distal end; b) a push rod having a proximal and a distalend, said push rod extending substantially through said hollow tube; c)a handle coupled to said proximal end of said tube; d) a lever pivotallycoupled to said handle and coupled to said proximal end of said push rodfor imparting axial movement to said push rod relative to said tube; e)a first jaw coupled to said distal end of said tube, said first jawbeing a die and having an open top including an upper opening and anopen bottom; f) a movable jaw pivotally coupled to said first jaw andcoupled to said distal end of said push rod, said movable jaw being apunch; and g) a sleeve removably engaging said first jaw,wherein whensaid movable jaw pivots relative to said first jaw towards a closedposition, said movable jaw punches the tissue and the tissue dropsthrough said open bottom of said first jaw into said sleeve.
 18. Asurgical punch instrument according to claim 17, wherein:said sleeveincludes a proximal opening, a top opening, and means for removablyengaging said first jaw, wherein said first jaw includes means forremovably engaging said removable sleeve.
 19. A surgical punchinstrument for cutting tissue, comprising:a) a hollow tube having aproximal and a distal end; b) a push rod having a proximal and a distalend, said push rod extending substantially through said hollow tube; c)actuation means coupled to said hollow tube and said push rod forimparting axial movement to said push rod relative to said tube; d) afirst jaw coupled to said distal end of said tube, said first jaw beinga die and having an open top including an upper opening and an openbottom; e) a movable jaw pivotally coupled to said first jaw and coupledto said distal end of said push rod, said movable jaw being a punch; andf) a sleeve removably engaging said first jaw,wherein when said movablejaw pivots relative to said first jaw towards a closed position, saidmovable jaw punches the tissue and the tissue drops through said openbottom of said first jaw into said removable sleeve.
 20. A surgicalpunch instrument according to claim 19, wherein:said sleeve includes aproximal opening, a top opening, and means for removably engaging saidfirst jaw, wherein said first jaw includes means for removably engagingsaid removable sleeve.